A Randomized, Double-Blind Clinical Trial to Evaluate the Non-Inferiority of the Efficacy and Safety of Dyston to Dysport for Preventive Treatment of Chronic Migraine Publisher



E Jafari ELHAM ; Dh Fetratjoo Delara HAZEGH ; Sm Afshani Seyyedeh MARYAM ; Z Salami ZHALE ; M Nayeri MOHAMMADREZA ; P Nazirzadeh PARDIS ; M Noormohammadi MORVARID ; M Togha MANSOUREH
Source: Neurology and Clinical Neuroscience Published:2025

Abstract

Background: Chronic Migraine (CM) is a highly disabling condition with a noticeable burden on the patients' lives. There are limited approved biologic medications for CM, one of which is Botulinum toxin. Objective: The aim of this randomized, double-blind, active-controlled clinical trial was to assess the non-inferiority of Dyston (manufactured by Imen Vaccine) compared to Dysport (IPSEN) in terms of efficacy and tolerability for the management of chronic migraine in adults. Methods: Chronic migraine patients aged 18 to 65 (inclusive) were randomly allocated in a 1:1 ratio to receive 500 IU Dyston or Dysport injections. The primary efficacy outcome measure was a 50% responder rate at the end of 16 weeks from baseline. Several secondary outcomes and adverse events were also assessed. Results: Ninety-two CM patients were randomized; the mean age was 40 (±9) years, and most patients (76.92%) were female. Twenty-six people in the Dysport group and 28 people in the Dyston group had a 50% or more decrease in the number of headache days at the end of the study period, and no significant difference was observed between the two groups in this regard (p value = 0.580). After calculating the risk difference, the subtraction of the lower confidence interval from the upper confidence interval (−0.40293) was smaller than the margin considered in this study. Conclusions: The result analysis of this study supports the non-inferiority of Dyston to Dysport in terms of efficacy and tolerability, based on the reduction of headache days by 50% when administered for preventive treatment of CM. Trial Registration: IRCT20201104049265N3. © 2025 Elsevier B.V., All rights reserved.